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15 Mar 2012, 11:40 am
820 Cases Are Filed In Federal Court NuvaRing MDL And 125 Lawsuits Are Part Of New Jersey State Court Mass Tort (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of NuvaRing lawsuits that had been filed before January 2012 comes from page 119 of the Merck & Co., Inc. [read post]
24 May 2007, 3:47 pm
In Comparison, Europe's Regulators Had Glaxo Change Avandia Label In 2006 To Include Warning About Risk Of Cardiac Ischemic Events Such As Heart Attacks (Posted by Tom Lamb at DrugInjuryWatch.com) In a May 24, 2007 New York Times (NYT) article about Avandia, Stephanie Sauls and Gardiner Harris reported the FDA was put on notice as far back as 2000 that there was concern in parts of the medical community about the cardiovascular safety of Avandia, a diabetes drug from… [read post]
3 Oct 2012, 11:00 am
Newly Available Expert Analysis Of Confidential Drug Company Data Reveals That NuvaRing Estrogen Levels In Studies Were A Cause For Concern, And The Method Of Reporting Was Misleading (Posted by Tom Lamb at DrugInjuryWatch.com) In the pending NuvaRing litigation a federal judge recently unsealed some significant documents previously protected under claims of confidentiality. [read post]
22 Aug 2008, 9:59 pm
FDA Rule Could Serve To Defeat Lawsuits Alleging Failure To Warn About Potentially Harmful Effects Of Prescription Drugs And Medical Devices (Posted by Tom Lamb at DrugInjuryWatch.com) Back in February 2008, in a post titled, "FDA Proposed Rule About Drug Label Warning Changes Will Lessen Agency's Power To Protect Us", I told you about a proposed rule that was issued in mid-January by the FDA. [read post]
9 Oct 2008, 3:59 pm
After Earlier Class 1 Recall Of Digitek, All Acvtavis Drugs Manufactured At Its Little Falls, NJ Plant Were Recalled In August 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 8, 2008 Representatives John D. [read post]
2 Feb 2009, 9:51 am
ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level (Posted by Tom Lamb at DrugInjuryWatch.com) In late December 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation, which covered "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following… [read post]
30 Oct 2012, 1:04 pm
Fresenius Failed To Warn About Risks Of Sudden Heart Attack, Stroke, And Death Caused By GranuFlo Increasing The Level Of Bicarbonate In Blood (Posted by Tom Lamb at DrugInjuryWatch.com) The dialysis product GranuFlo from Fresenius was used by approximately one-third of the 400,000 patients with late-stage kidney failure requiring dialysis per year at a time when Fresenius apparently knew that GranuFlo caused an increased risk of metabolic alkalosis that could result in… [read post]
10 Nov 2010, 5:55 am
Patients Have No Legal Claim Due To Federal Preemption Ruling (Posted by Tom Lamb at DrugInjuryWatch.com) As those who have been following the Sprint Fidelis litigation know by now, the thousands of product liability lawsuits that had been filed in connection with the defective lead wire recall by Medtronic did not go the way that injured plaintiffs had hoped. [read post]
14 Jan 2011, 11:14 am
Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Multaq "safety warning" issued by European drug regulator MHRA on January 21, 2011: "New information on possible risk of liver injury with dronedarone (Multaq)" Includes "Dear Doctor" letter sent by… [read post]
10 Aug 2009, 11:43 am
Important Safety Information For Women Who Are Currently Using YAZ / Yasmin / Ocella, NuvaRing, Or Ortho Evra For Contraception Or Hormone Replacement Therapy (Posted by Tom Lamb at DrugInjuryWatch.com) For women who are using estrogen-progestin methods of birth control, here is some important information from WebMD's Birth Control Health Center about the symptoms of some serious, potentially fatal side effects: The following symptoms, called… [read post]
6 Feb 2012, 2:17 pm
Reason Is That Bayer Has Been Supplying Teva And Barr With The Product For Their Gianvi Pills Since December 2010 (Agreement Is Similar To Ocella Deal) (Posted by Tom Lamb at DrugInjuryWatch.com) Gianvi, a generic version of YAZ, is marketed by Teva Pharmaceuticals and Barr Laboratories, which are commonly referred to as generic drug companies. [read post]
23 Feb 2010, 1:34 pm
Heart Risk Is Current Focus Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed The Liver Failure Case Reports Linked To Avandia, Also(Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, in October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S. because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and… [read post]
2 May 2011, 1:12 pm
April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis (Posted by Tom Lamb at DrugInjuryWatch.com) According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin)… [read post]
22 May 2012, 1:11 pm
Using These Bisphosphonates More Than Three (3) To Five (5) Years May Not Only Increase Side Effect Risk But There May Be No Benefit To Most Patients (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2012 there were medical journal articles in The New England Journal of Medicine (NEJM) and the Archives of Internal Medicine which, together, may cause millions of women to stop using the popular osteoporosis drugs Fosamax (or alendronate, its generic equivalent), Boniva,… [read post]
27 Jun 2008, 6:54 pm
Supreme Court (Posted by Tom Lamb at DrugInjuryWatch.com) On June 26, 2008 Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.) along with 62 bipartisan supporters introduced HR 6381, the Medical Device Safety Act of 2008. [read post]
9 May 2012, 12:51 pm
825 Lawsuits Are Part Of New Jersey State Court Mass Tort Consolidation; Majority Of Other Cases Are Filed In "Second" Fosamax Federal Court MDL (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of Fosamax - femur fracture lawsuits that had been filed before January 2012 comes from pages 117-118 of the Merck & Co., Inc. [read post]
30 Sep 2010, 1:18 pm
Two More Fosamax Lawsuits Involving Jaw Injury Like Osteonecrosis Of The Jaw (ONJ) Will Go To Trial In Spring 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) _______________________________________________________________________________ UPDATE: Merck Not at Fault in Fosamax Trial, Jurors Say (New York Times, 11/19/10) ... [read post]
Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market?
9 Nov 2007, 9:03 am
One Wonders Whether GSK Might Do A "Soft" Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years (Posted by Tom Lamb at DrugInjuryWatch.com) Avandia (rosiglitazone) is a prescription drug from GlaxoSmithKline (GSK) approved by the FDA in 1999 to treat Type 2 diabetes. [read post]
31 Aug 2012, 2:30 pm
Approved By FDA In 2010, There Has Been No Study Done Yet Regarding Beyaz Safety -- Despite Significant Number Of Beyaz Adverse Event Reports (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Meeting Materials for Pediatric Focused Safety Review: Beyaz (ethinyl estradiol, drospirenone, levomefolate calcium) Pediatric Advisory Committee Meeting September 11, 2012 (PowerPoint PDF) (9/19/12)… [read post]
28 Mar 2008, 7:42 am
A Couple Of Recent Offerings From Our Readers, For Your Consideration (Posted by Tom Lamb at DrugInjuryWatch.com) As you will see, we have two readers who emailed me recently to thank for today's post. [read post]
